A Phase 1 Study To Estimate The Relative Bioavailability Of Co-Administered Formulations Of Azithromycin Microsphere And Chloroquine Test Formulation Compared With Co-Administered Immediate Release Individual Azithromycin And Chloroquine Tablets In Healthy Adult Subjects

A Phase 1, Open-Label, Randomized, Single Dose, Parallel Design Study To Estimate The Relative Bioavailability Of Co Administered Formulations Of Azithromycin Microsphere (AZ) And Chloroquine Test Formulation (CQ) Compared With Co Administered Immediate Release Individual AZ And CQ Tablets In Healthy Adult Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01100060

Acronym

AZCQ

Enrollment

Registered

2010-04-08

Start date

2010-04-30

Completion date

2010-06-30

Last updated

2010-08-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malaria Prophylaxis

Keywords

Azithromycin, chloroquine, microsphere, pharmacokinetics, bioavailability

Brief summary

Estimate the relative bioavailability of co-administered azithromycin microsphere (2000 mg) and the chloroquine (620 mg CQ base) test formulation compared to co-administered immediate release individual tablets of azithromycin (2000 mg) and chloroquine (600 mg CQ base) in healthy adult subjects.

Detailed description

Evaluate the relative bioavailability, assessment of the safety and tolerability of azithromycin microsphere and the chloroquine test formulation compared to immediate release individual tablets.

Interventions

DRUGazithromycin (AZ) microsphere

AZ microsphere (2000 mg) single dose on Day 1.

DRUGtest chloroquine (CQ) formulation

Test CQ formulation, 620 mg CQ base, single dose on Day 1.

DRUGazithromycin (AZ)

AZ IR 4 x 500 mg tablets, single dose on Day 1.

DRUGchloroquine (CQ)

CQ 2 x 500 mg (600 mg CQ base) tablets, single dose on Day 1

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ECG and clinical laboratory tests). * Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs). * An informed consent document signed and dated by the subject or a legally acceptable representative. * Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

Exclusion criteria

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing). * History of febrile illness within 5 days prior to first dose. * Treatment with azithromycin within the past 30 days or with chloroquine within the past 45 days. * Known immediate family history of prolonged QT Syndrome, serious ventricular arrhythmia, or sudden cardiac death. Immediate is considered first degree. * Known allergy to macrolide antibiotics (eg, erythromycin, clarithromycin, azithromycin) or chloroquine (or other 4 aminoquinolines) or severe allergic reaction to any drug in the past (eg, difficulty breathing, anaphylaxis). * History of intolerance to azithromycin or chloroquine.

Design outcomes

Primary

Measure	Time frame
AUClast of azithromycin and chloroquine	Through Day 5

Secondary

Measure	Time frame
Tmax and Cmax of azithromycin and chloroquine.	Through Day 5
AUClast, Tmax, and Cmax of desethylchloroquine.	Through Day 5

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026